The primary goal of the Biostatistics Shared Resource (BioSR) is to facilitate the peer-reviewed research of members of the Comprehensive Cancer Center at Wake Forest University (CCCWFU). We collaborate with members from all four programs (Cell Growth and Survival, Clinical Research, Cancer Prevention and Control, and Cellular Damage and Defense) throughout all phases of cancer-related research projects. Major responsibilities are assumed for methodological, statistical, and computer-related issues including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews, and final analysis. Specifically, the BioSR supports the following five areas 1) Protocol Development, i.e., developing appropriate statistical designs, preparing statistical sections, and reviewing the statistical content of all protocols submitted for review at the CCCWFU; 2) Protocol Monitoring, i.e., monitoring patient accrual and performing interim analyses when needed; 3) Statistical Analyses and Publications, i.e., collaborating with CCCWFU investigators from all programs to provide statistical analyses of data and interpretations of results to assist in publications of findings; 4) New Grant Development, i.e., meeting with CCCWFU investigators to discuss the design and analysis plans for potential grants as well as conducting regular grant assistance planning sessions to brainstorm with CCCWFU investigators about potential grants; and 5) Leadership and Training, i.e., participating in CCCWFU committees responsible for scientific and administrative decisions and conducting a monthly seminar series in topics in research methods for CCCWFU members. The BioSR is a highly utilized and cost efficient resource for the CCCWFU. From Nov. 1, 2009 through Oct. 31, 2010, the BioSR provided over 5,000 hours of support for cancer related work. During the same time period, the BioSR assisted over 115 different investigators (71 Scientific members) from all Programs and Centers of Excellence within the CCCWFU. In addition, 20 investigator-initiated institutional protocols were opened, 30 investigator-initiated institutional protocols were monitored, 20 manuscripts (in 2010) were published and over 30 grants submitted with the assistance of the BioSR during this time. For the coming grant period we request at total of 2.45 FTEs of support divided into statistical, administrative and programming support to provide these continued services.